Low Endotoxin Recovery/Masking
Im Auftrag der European compliance Academy

Im Auftrag der European Compliance Academy

Low Endotoxin Recovery/Masking Im Auftrag der European compliance Academy <p>Im Auftrag der European Compliance Academy

Munich/Bernried, Germany

Seminar Nr. 15413

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Sprecher

Dr Friedrich von Wintzingerode
Roche Diagnostics GmbH
Stefan Gärtner
L+S AG
Dr. Ingo Ciolkowski
Lonza AG
Johannes Reich
University of Regensburg
Dr Holger Grallert
Hyglos GmbH
Thomas Potrawfke
Haemochrom Diagnostica
Marion Usedom
Charles River Laboratories

Zielsetzung

How to identify Low Endotoxin Recovery (LER)
How to Set-up hold-time studies
Analysis of influencing factors (Sample matrices, endotoxin, temperature, detection methods, etc.)
Understanding the driving forces of LER
Interpretation of test results
Dedicated sample treatment for demasking

Hintergrund

In the last years the LAL test has become the preferred system to test for endotoxins – for the in-process control as well as in the final inspection – and it is anchored in the pharmacopoeias. However, in the recent past, the problem of low endotoxin recovery employs the pharmaceutical microbiology. Masking – or not? Evidence gaps? And how can I close them? And how to evaluate?

These are the questions the pharmaceutical microbiologists as well as those responsible for the release have to deal with.

And last but not least, how can we handle the test in daily business in a practical manner.

Zielgruppe

Laboratory management and staff of pharmaceutical microbiology
Microbiologists and laboratory assistants from contract laboratories
Scientific staff from the area Endotoxin testing

Programm

Endotoxin Detection Methods I
Definition of Endotoxins
Nature of Endotoxin
General detection methods
Thomas Potrawfke, Haemochrom Diagnostica

Endotoxin Detection Methods II
Basic reaction of Limulus-based detection methods
Sample handling
Construction and interpretation of standard curve
Dr. Ingo Ciolkowski, Lonza AG

Utilizing high speed atomic force microscopy (HSAFM) to observe the conformational changes and stability of LPS, in the presence of detergents, and its impact on biological activity and LER. Mechanisms of LER can be influenced by LPS stability
Varying size and fragility of LPS aggregates can be directly correlated to presence of chelating agents and detergents
Elucidating conformational changes, in real time, on LPS using HSAFM
Marion Usedom, CRL

Test Interference
Postitive Product Control (PPC)
Test inhibition
Test enhancement
Stefan Gärtner, L+S

Endotoxin Recovery Studies for the Detection of Endotoxin Masking Effects
Endotoxin Masking
Planning and implementation of hold-time studies
Interpretation of hold-time studies
Dr Friedrich von Wintzingerode, Roche Diagnostics GmbH

Demasking of Endotoxin
Mechanistic principles of demasking
Development of demasking protocols
Implementation of demasking protocols
Johannes Reich, University Regensburg

Sample Preparation for Demasking
Practical demasking procedure
Preparation of reagents for demasking
Application of demasking protocols
Dr Holger Grallert, Hyglos

Round Table Discussion

Practical Laboratory Work:
(Microcoat GmbH)


Simulation of contamination in various sample
matrices
Preparation of samples affected by
Test interference
Sample interference
Endotoxin Service Team, Microcoat GmbH

Analysis of interference in affected samples
Application of different detection systems
Limulus Amebocyte Lysate assay
Recombinant Factor C assay
Endotoxin Service Team, Microcoat GmbH

Sample treatment for demasking
Screening for demasking protocol
Optimization of demasking protocol
Evaluation of demasking protocol
Endotoxin Service Team, Microcoat GmbH

Interpretation and Comparison of Results
Differentiation between test and sample interference
Effects of different detection systems
Demasking of endotoxin
Endotoxin Service Team, Microcoat GmbH

Closing Remarks (ECA Academy)


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